Back to resultsA Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
RG3421 120mg
RG3421 20mg
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- adult patients, 18-70 years of age;
- medically stable, moderate to severe chronic plaque psoriasis.
Exclusion Criteria:
- any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
- confounding or concomitant condition or treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
RG3421 120mg
RG3421 20mg
Arm Description
po daily
120mg po daily
20mg po daily
Outcomes
Primary Outcome Measures
Adverse events (AEs), laboratory parameters, pharmacokinetics
Secondary Outcome Measures
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00504270
Brief Title
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Official Title
A Randomized, Placebo-controlled Dose-ranging Pilot Study to Assess the Effect on Clinical Response, and the Safety and Tolerability of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
po daily
Arm Title
RG3421 120mg
Arm Type
Experimental
Arm Description
120mg po daily
Arm Title
RG3421 20mg
Arm Type
Experimental
Arm Description
20mg po daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po daily
Intervention Type
Drug
Intervention Name(s)
RG3421 120mg
Intervention Description
120mg po daily
Intervention Type
Drug
Intervention Name(s)
RG3421 20mg
Intervention Description
20mg po daily
Primary Outcome Measure Information:
Title
Adverse events (AEs), laboratory parameters, pharmacokinetics
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, 18-70 years of age;
medically stable, moderate to severe chronic plaque psoriasis.
Exclusion Criteria:
any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
confounding or concomitant condition or treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
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